600 Participants Needed

Viaskin Peanut for Peanut Allergy

(VITESSE Trial)

Recruiting at 88 trial locations
SR
RT
DT
Overseen ByDBV Technologies
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on immunotherapy for any allergen or have used certain treatments like monoclonal antibodies within 6 months before the trial.

Is Viaskin Peanut safe for people with peanut allergies?

Viaskin Peanut, used in epicutaneous immunotherapy (a treatment applied to the skin), has been well tolerated in clinical trials for peanut-allergic children, showing it is generally safe for use in humans.12345

How is the Viaskin Peanut treatment different from other peanut allergy treatments?

Viaskin Peanut is unique because it uses a patch to deliver small amounts of peanut protein through the skin, which helps desensitize the immune system to peanuts. This method, known as epicutaneous immunotherapy, is different from other treatments that might involve oral ingestion or avoidance strategies.12456

What data supports the effectiveness of the treatment Viaskin Peanut for peanut allergy?

Research shows that Viaskin Peanut, a patch containing peanut protein, is more effective than a placebo in helping children with peanut allergies become less sensitive to peanuts. This means that children using the patch can tolerate more peanuts without having an allergic reaction.12578

Are You a Good Fit for This Trial?

This trial is for peanut-allergic children aged 4-7 who react to a very small amount of peanut protein and are on a strict peanut-free diet. They must have certain levels of peanut-specific antibodies and skin test reactions. Kids with uncontrolled asthma, past immunotherapy for peanuts, or recent biologic treatments can't join.

Inclusion Criteria

Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1
Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet
I am between 4 and 7 years old.
See 1 more

Exclusion Criteria

I have severe skin disease on my upper back.
My asthma symptoms are not well-controlled.
I have received or am receiving immunotherapy for peanut allergy.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
2 visits (in-person)

Treatment

Participants receive daily DBV712 250 mcg or placebo for 12 months to assess efficacy and safety in inducing desensitization to peanut

12 months
Monthly visits (in-person)

Open-label Extension

Participants apply DBV712 250 mcg daily for an additional 24 or 36 months, depending on initial randomization, to continue treatment and assess sustained unresponsiveness

24-36 months
Annual visits (in-person)

Follow-up

Participants are monitored for sustained unresponsiveness through open food challenges at 2, 4, and 6 months off treatment

6 months
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • DBV712
  • Placebo
Trial Overview The study tests the safety and effectiveness of DBV712 (250 mcg), a daily treatment aimed at desensitizing children to peanuts over one year. The comparison is made against a placebo—a substance with no active drug—to see if DBV712 makes any difference.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open Label Extension Period: DBV712 250 mcgExperimental Treatment1 Intervention
Group II: DBPC Treatment Period: DBV712 250 mcgExperimental Treatment1 Intervention
Group III: DBPC Treatment Period: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

DBV Technologies

Lead Sponsor

Trials
17
Recruited
3,500+

Citations

Immune response evolution in peanut epicutaneous immunotherapy for peanut-allergic children. [2023]
Treatment of peanut allergy with rush immunotherapy. [2022]
Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results. [2022]
Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. [2022]
Assessing the efficacy of oral immunotherapy for the desensitisation of peanut allergy in children (STOP II): a phase 2 randomised controlled trial: a critical appraisal. [2022]
Allergy to peanut oil--clinically relevant? [2017]
Efficacy and safety of peanut epicutaneous immunotherapy in patients with atopic comorbidities. [2023]
Targeted allergen-specific immunotherapy within the skin improves allergen delivery to induce desensitization to peanut. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security